Actively Recruiting

Age: 18Years - 60Years
All Genders
ID04458688

Investigating the Effect of Ocrelizumab in African Americans and Caucasians With Relapsing Multiple Sclerosis Using MRI and OCT-A Imaging

Led by Wayne State University · Updated on 2022-06-06

80

Participants Needed

1

Research Sites

282 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating how the drug ocrelizumab affects the disease course of relapsing multiple sclerosis (RMS) in African American patients compared to Caucasian patients. This study focuses on using advanced imaging techniques like magnetic resonance imaging (MRI) and optical coherence tomography angiography (OCT-A) to observe differences in disease progression and injury patterns between these groups. Previous studies have shown that African Americans with MS may experience a more aggressive disease course and more eye damage than Caucasians. The study observes patients who have already decided to start or recently started ocrelizumab as their disease-modifying therapy for RMS. Participants include 40 African American and 40 Caucasian patients, matched by age, sex, disease duration, and disability level. The study involves five visits spaced six months apart over two years, during which MRI and OCT-A scans will be performed to track changes. Participants will attend scheduled visits every six months for two years, undergoing MRI scans with contrast at baseline, 6, 12, and 24 months, and OCT-A scans at baseline, 12, and 24 months. Researchers will measure changes in imaging results to assess disease activity and eye layer injury. The study includes safety monitoring and will collect clinical data to better understand how ocrelizumab works in different ethnic groups with RMS.

CONDITIONS

Brief Title

Investigating the Effect of Ocrelizumab in African Americans and Caucasians With Relapsing Multiple Sclerosis

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who have decided to start ocrelizumab as their disease modifying therapy as determined appropriate by their neurologist
  • May be treatment naive or have had no more than one prior disease modifying therapy after at least 6 months of treatment
  • Age between 18 and 60 years old
  • Self-identify as African American or Caucasian
  • Clinically definite relapsing remitting multiple sclerosis according to 2017 McDonald criteria
  • Expanded Disability Status Scale (EDSS) score from 0 to 6 at baseline
  • Able to provide informed consent
  • Able to undergo MRI scans
Not Eligible

You will not qualify if you...

  • Treatment with another monoclonal antibody such as natalizumab, alemtuzumab, or daclizumab
  • Failed two or more disease modifying therapies
  • Use of immunosuppressant drugs like chemotherapy agents
  • Claustrophobia
  • Allergy to contrast agents
  • Significant medical problems interfering with study participation as determined by the investigator
  • Relapse or corticosteroid use within 30 days before baseline visit
  • Pregnancy
  • History of kidney or liver failure
  • History of cancer

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - 2 years

Participants who have decided to start ocrelizumab as their disease modifying therapy are observed over time using imaging measures including MRI and OCTA to assess changes in their condition.

5 visits at six-month intervals

Trial Site Locations

Total: 1 location

1

Wayne State University

Detroit, Michigan, United States, 48201

Actively Recruiting

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Research Team

Z

Zahid Latif

K

Kelly Jia

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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